Volume 70, Issue 3, Pages 483-493 (March 2019) Effect of NGM282, an FGF19 analogue, in primary sclerosing cholangitis: A multicenter, randomized, double-blind, placebo-controlled phase II trial  Gideon M. Hirschfield, Olivier Chazouillères, Joost P. Drenth, Douglas Thorburn, Stephen A. Harrison, Charles S. Landis, Marlyn J. Mayo, Andrew J. Muir, James F. Trotter, Diana J. Leeming, Morten A. Karsdal, Mark J. Jaros, Lei Ling, Kathline H. Kim, Stephen J. Rossi, Ransi M. Somaratne, Alex M. DePaoli, Ulrich Beuers  Journal of Hepatology  Volume 70, Issue 3, Pages 483-493 (March 2019) DOI: 10.1016/j.jhep.2018.10.035 Copyright © 2018 European Association for the Study of the Liver Terms and Conditions

Journal of Hepatology 2019 70, 483-493DOI: (10. 1016/j. jhep. 2018. 10 Copyright © 2018 European Association for the Study of the Liver Terms and Conditions

Fig. 1 Trial profile. AE, adverse event; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase. Journal of Hepatology 2019 70, 483-493DOI: (10.1016/j.jhep.2018.10.035) Copyright © 2018 European Association for the Study of the Liver Terms and Conditions

Fig. 2 Key outcome measures. (A) Serum levels of ALP at baseline and week 12. (B) Serum levels of C4 at baseline and week 12. (C) Serum levels of total endogenous bile acids at baseline and week 12. (D) Change in ALT from baseline over time. (E) Change in AST from baseline over time. All data are mean ± SEM. Statistical tests were ANCOVA (panels A-C) or mixed-effect model repeated measures (panels D-E) analyses. *p <0.05, **p <0.01, ***p <0.001. ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; C4, 7alpha-hydroxy-4-cholesten-3-one; EOT, end of treatment at week 12. Journal of Hepatology 2019 70, 483-493DOI: (10.1016/j.jhep.2018.10.035) Copyright © 2018 European Association for the Study of the Liver Terms and Conditions

Fig. 3 Changes in biomarkers of liver fibrosis. (A) Change in ELF from baseline to week 12. Left panel: all patients; middle panel: patients with baseline ELF ≤9.8; right panel: patient with baseline ELF >9.8. (B) Serum concentrations of Pro-C3 over time. (C) Percent change in Pro-C3 from baseline over time. All data are mean ± s.e.m. Statistical tests were ANCOVA (panel A) or mixed-effect model repeated measures (panels B-C) analyses. *p <0.05, **p <0.01, ***p <0.001. ELF, Enhanced Liver Fibrosis score; EOT, end of treatment at week 12; FU, follow-up at week 16; Pro-C3, neoepitope-specific N-terminal propeptide of type III collagen. Journal of Hepatology 2019 70, 483-493DOI: (10.1016/j.jhep.2018.10.035) Copyright © 2018 European Association for the Study of the Liver Terms and Conditions